Question 1

Is there a generic for Perfluorohexyloctane?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Perfluorohexyloctane. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Perfluorohexyloctane?

Accepted Answer

MIEBO (NDA 216675, BAUSCH AND LOMB INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Perfluorohexyloctane?

Accepted Answer

The Orange Book lists 6 patents against Perfluorohexyloctane products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Perfluorohexyloctane have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Perfluorohexyloctane. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Perfluorohexyloctane are approved?

Accepted Answer

Perfluorohexyloctane is approved in the following dosage form: solution/drops.

Patent	Expires	In	Type
10449164	Sep 12, 2033	in 7 yr 4 mo	U-1900
10369117	Sep 12, 2033	in 7 yr 4 mo	U-1900
10058615	Sep 12, 2033	in 7 yr 4 mo	U-1900
10576154	Oct 01, 2035	in 9 yr 5 mo	U-1900
11357738	Sep 29, 2036	in 10 yr 5 mo	Product
10507132	Jun 21, 2037	in 11 yr 2 mo	U-1900

Perfluorohexyloctane

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (6)

Perfluorohexyloctane — frequently asked questions

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